University Hospitals Seidman Cancer Center launched a new clinical trial for CAR-T, joining a select group of hospitals offering the therapy and a smaller group of hospitals manufacturing the CAR-T cells.

CAR-T therapy has been called a "living drug" and is part of a rapidly emerging immunotherapy approach called adoptive cell transfer (ACT), which collects and uses patients' own immune cells to treat their cancer. There are several types of ACT, but CAR-T cell therapy is showing the most promise in clinical development, according to the National Institutes of Health (NIH).

UH's clinical trial will use CAR-T cells made from a patient's own genetically-modified white blood cells, called T-cells, to boost their immune system to detect and attack their cancer.

The Phase I clinical trial, funded by UH Seidman, will study the safety of CAR-T therapy for Non-Hodgkin's lymphoma, a cancer that starts in white blood cells called lymphocytes. The clinical trial aims to enroll 12 to 15 current UH adult patients with Non-Hodgkin's lymphoma who have not responded to standard therapies. Paolo Caimi, MD, hematologist/oncologist at UH Seidman and Associate Professor of Medicine at Case Western Reserve University School of Medicine, serves as the principal investigator of the study.

The primary advantage of CAR-T therapy is an increase in remission and survival. A landmark study published in the New England Journal of Medicine in 2017 showed that 42 percent of lymphoma patients who underwent CAR-T treatment were in complete remission after a median follow-up of 15.4 months. The treatment was for patients who had failed earlier treatments with other methods.

"CAR-T cell therapy has a huge potential to cure leukemias and lymphomas," said Dr. Marcos de Lima, MD, Director of Hematologic Malignancies and the Stem Cell Transplant Program at UH Seidman and Professor of Medicine at CWRU School of Medicine. "It's not a widespread application yet, but the potential is huge."

What sets UH Seidman apart is that it is one of the few hospitals that has the ability to manufacture the cells on site in the shared CWRU National Center for Regenerative Medicine and the UH Seidman Cellular Therapy Laboratory in the Wolstein Research Building. This provides the benefit of time for patients.

"Having the ability to make cells on-site means there will be a shorter turn-around time in having the cells available for the patient compared to shipping them off-site," said Dr. Caimi.

Additionally, UH uses the CliniMACS Prodigy, a closed system which prevents exposure to air, to genetically modify and grow the CAR-T cells. The Prodigy system helps to enhance safety and save personnel time and cleanroom use costs. It also has significant applications for future research.

"It's a platform that opens a lot of possibilities for us. Tomorrow an investigator may discover a new target, so we have the whole machinery to execute that. The sky is the limit. It's not only a tool for the present, but a very solid investment for the future," said Dr. de Lima.

Looking to the future of CAR-T therapy, Dr. de Lima said the day will come when cancer patients are prescribed generic CAR-T cells like any other drug, avoiding the cumbersome process of collecting, re-engineering, culturing and re-administering cells to individuals.

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